1. Technical Field
The present disclosure relates generally to packaging for medical devices, and more particularly, to a package for applying a predetermined amount of at least one target agent to a medical device. The packages described herein include a container for receiving a medical device, wherein at least a portion of the medical device is prepared to receive the target agent and a port in communication with the container for allowing the sterile passage of the target agent to the prepared portions of the device.
2. Background of Related Art
Combination medical devices, i.e., medical devices coated with drugs or other bioactive agents, have become more prevalent commercially in recent years. There are many of these combination medical devices known to those skilled in the art. Many of these devices require specialized coatings to facilitate both bioactive agent elution and, more importantly, maintain or enhance the core functionality of the medical device. For example, a suture containing an antimicrobial coating must be able to facilitate the elution of the antimicrobial agent in the coating and also maintain a certain tensile strength, handling ability, knot-tying ability, and degradation rate to ensure the coated suture remains functional as a wound closure device.
In addition, significant interest has recently been placed on coupling target agents, i.e., drugs, biological molecules, etc., to the surface of a medical device to improve clinical outcomes related to improved biocompatibility, reduced implant rejection, fibrous encapsulation, localized drug delivery, and reduced infection. Much of this work has focused on using some form of chemical coupling to bridge common drugs, such as chemotherapy agents, anti-infectives, anti-inflammatories, etc., or biologics, i.e., cells, peptides, fibronectin, etc., to the surface of a medical device. It would be advantageous to have a package for receiving a medical device having a surface prepared to receive a target agent which maintained sterility while allowing for the passage of a target agent between the prepared surface of the medical device and the outside of the package.
Therefore, the present disclosure describes a package for a medical device aimed at simplifying the addition of a target agent to the prepared surface of a medical device, as well as maintaining the sterile conditions in which the addition of the target agent is conducted.